510(k) K070915
K070915 is an FDA 510(k) premarket notification submitted by Sapimed S.P.A. for the device "SAPIMED DISPOSABLE SIGMOIDOSCOPE". The FDA issued a decision of Substantially Equivalent on July 6, 2007. The device falls under product code KDM (Sigmoidoscope, Rigid, Non-Electrical), a Class II device regulated under 21 CFR 876.1500. Sapimed S.P.A. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2007
- Date Received
- April 2, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sigmoidoscope, Rigid, Non-Electrical
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type